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TESARO Inc (TSRO.OQ)

TSRO.OQ on NASDAQ Stock Exchange Global Select Market

151.88USD
29 Mar 2017
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Latest Key Developments (Source: Significant Developments)

FDA approves Tesaro's ovarian cancer drug
Monday, 27 Mar 2017 04:05pm EDT 

U.S. FDA: U.S. FDA granted the approval of Zejula to Tesaro Inc . U.S. FDA - FDA granted the application fast track, priority review and breakthrough therapy designations . U.S. FDA - Zejula also received orphan drug designation specifically for its use in treating recurrent epithelial ovarian cancer . U.S. FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers Further company coverage: [TSRO.O] ((Bangalore.newsroom@thomsonreuters.com;)).  Full Article

TESARO announces U.S. FDA approval of zejula for women with recurrent ovarian cancer
Monday, 27 Mar 2017 03:47pm EDT 

TESARO Inc - : TESARO announces U.S. FDA approval of zejula™ (niraparib) for women with recurrent ovarian cancer . TESARO anticipates launching zejula in United States in late April .Marketing authorisation application for niraparib is under review by European Medicines Agency.  Full Article

Tesaro to expand development program for Niraparib drug
Monday, 27 Mar 2017 03:45pm EDT 

Tesaro Inc : Tesaro announces expanded development program for Niraparib focused on the treatment of front-line metastatic ovarian and lung cancers and metastatic breast cancer .Tesaro - also expect to initiate new trial of Niraparib in combination with anti-pd-1 antibody in women with metastatic triple-negative breast cancer.  Full Article

Tesaro reports Niraparib phase 3 ENGOT-OV16/NOVA trial secondary endpoint results
Monday, 13 Mar 2017 11:10am EDT 

Tesaro Inc : Tesaro announces presentation of niraparib phase 3 ENGOT-OV16/NOVA trial secondary endpoint results during SGO . Niraparib had no impact on efficacy of next-line therapy . Niraparib significantly improved chemotherapy-free interval among patients who were germline brca mutation carriers . PFS-2 data were statistically significant and favored Niraparib over control for patients in both gbrcamut cohort, non-gbrcamut cohort . Progression-free surivival-2 and overall survival are immature, but favor Niraparib .Among patients without Germline BRCA mutations, Niraparib arm successfully achieved statistical significance over control arm for secondary endpoint of CFI.  Full Article

Tesaro Q4 loss per share $2.60
Tuesday, 28 Feb 2017 04:05pm EST 

Tesaro Inc : Tesaro announces fourth-quarter 2016 operating results . Q4 loss per share $2.60 . Q4 revenue $4.2 million versus $200,000 . Q4 revenue view $5.8 million -- Thomson Reuters I/B/E/S .Q4 earnings per share view $-1.95 -- Thomson Reuters I/B/E/S.  Full Article

Tesaro expects to have sold about 9,165 Varubi units in quarter ended Dec. 31
Monday, 9 Jan 2017 09:00am EST 

Tesaro Inc :Sees total number of units of Varubi sold by company in quarter ended December 31, 2016 were approximately 9,165 units.  Full Article

Tesaro announces priority review designation for niraparib nda
Tuesday, 20 Dec 2016 08:00am EST 

Tesaro Inc : Tesaro announces priority review designation for Niraparib NDA . FDA has established a target action date under prescription drug user fee act of June 30, 2017 .An expanded access program (EAP) for Niraparib in United States is planned to open in January 2017.  Full Article

Tesaro announces pricing of public offering of common stock
Tuesday, 15 Nov 2016 09:30am EST 

Tesaro Inc : Priced an underwritten public offering of an aggregate of 1.75 million shares of common stock at offering price to public of $135.00/share .Tesaro announces pricing of public offering of common stock.  Full Article

Tesaro announces third-quarter 2016 operating results
Thursday, 3 Nov 2016 04:05pm EDT 

Tesaro Inc : Tesaro Inc says pre-launch planning ongoing to support four potential product launches in 2017 across U.S. and Europe . Tesaro announces third-quarter 2016 operating results . Q3 loss per share $1.98 .Q3 earnings per share view $-1.92 -- Thomson Reuters I/B/E/S.  Full Article

Tesaro announces acceptance for review of niraparib Marketing Authorization Application by EMA
Thursday, 27 Oct 2016 04:05pm EDT 

Tesaro Inc : Tesaro announces acceptance for review of niraparib Marketing Authorization Application by Ema . Tesaro inc says with this acceptance, review of niraparib Marketing Authorisation Application in centralised procedure will now begin .Well positioned for two potential product launches in EUROPE in 2017.  Full Article

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